To determine the occurrence of Post Kala-Azar Dermal Leishmaniasis (PKDL) in Visceral Leishmaniasis (VL) patients treated with new treatments in Bihar
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Visceral Leishmaniasis (VL), also known as Kala Azar and Post Kala Azar Dermal Leishmaniasis patients
- Registration Number
- CTRI/2016/06/007020
- Lead Sponsor
- Drugs for Neglected Diseases initiative DNDi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1622
Inclusion Criteria
All cases that have been previously diagnosed with sign and symptoms of Kala Azar and were rK 39 test or parasitology positive (by the time of the Kala Azar diagnosis)
-All KA cases that have been previously treated with one of three regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin, Ambisome and Miltefosine combination over period Aug 2012 to Oct 2014 in pilot implementation study
-Written voluntary informed consent to participate in the study
Exclusion Criteria
-Patients who are unwilling to participate in the study or guardian/Legal Acceptable Representative unwilling to provide written informed consent will be excluded from the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the prevalence rate of Post Kala Azar Dermal Leishmaniasis (PKDL) during or more than 24 months post treatment in Kala Azar treated cases with any of the three treatment regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 daysTimepoint: Follow up of VL patients treated earlier for atleast 24 months after receiving VL treatment
- Secondary Outcome Measures
Name Time Method To compare occurrence of PKDL in different treatment armsTimepoint: Follow up of treated patients for atleast 24 months;To determine the average time of occurrence of PKDL after each treatmentTimepoint: Follow up of patients for atleast 24 months